Clinical Sr. QA Specialist - CLIA/CAP

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Taking care of people is at the heart of everything we do, and we start by taking care of you! A career at Grifols means experiencing our culture of caring. It’s an opportunity to do something meaningful, each day. It means sharpening your skills and growing your career. And it means working in an environment that celebrates diversity and is fair and inclusive.

About the Role

The QA Sr. Specialist plays a pivotal role in laboratory operations, providing essential oversight and guidance, with a primary focus on clinical and manufacturing testing. Their multifaceted responsibilities encompass complaint handling, customer support, leading improvement initiatives, and meticulous document review. In addition, they serve as the key interface between quality assurance and auditing bodies, facilitating effective communication with both external auditors and internal departments. They may also supervise relevant tasks without formal evaluations.

Responsibilities

• Independently handles complaints, investigations, performs root cause analysis, and assigns additional actions as necessary.
• Review, update, and create SOPs to standardize current and new processes.
• Applies knowledge of regulatory bodies such as CAP, CLIA, AABB, and CFR to identify, manage, and follow up on Quality events.
• Leads cross-functional teams from internal departments and outside vendors to establish appropriate processes for product quality improvements. Ensures implementation, sustainability, and monitors the field quality of the improvements.
• Represents QA interests on special projects related to area of expertise.
• Plans and conducts scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements. Includes audit scheduling, investigation, evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
• Proactively investigates, identifies, and implements best-in-class Quality Systems practices and manages improvement projects within the organization (CAPA, QMP, StAR, Lean, 5S).
• Drives awareness and compliance with applicable standard operating procedures, work instructions, standards, and regulations to meet, comply with, and champion all quality and regulatory commitments.
• Interacts with regulatory and partner auditors/inspectors.
• Estimates, plans, schedules, and reviews own and others’ work products and is accountable for the quality of work delivered.

Requirements

• Requires a BA or BS in biology, chemistry, biochemistry, or any science-related field. Quality certifications such as MT, MLS, CLS, and ASQ or equivalent are a plus.
• 5-8 years of related quality experience in complaint handling and investigation, or a Master’s degree with 3-6 years of experience.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Skills

• Advanced knowledge of complaint handling, testing instruments (hardware and software), QC, manufacturing, and inventory processes.
• Working knowledge of QMS, Microsoft Word, Excel (or other data trending/analysis tools), PowerPoint, and related functions including the formulation of graphs.
• Organizational skills, attention to detail, and ability to prioritize in a fast-paced environment.
• Must demonstrate initiative, independence, balanced assertiveness, flexibility, and team orientation.
• Ability to train and mentor within and outside the group.
• Can plan and coordinate own work according to higher-level project schedules, including direction of contract personnel to ensure projects come to fruition in a timely manner.

Benefits

• Salary in line with the market as well as an annual bonus target.
• Paid vacation, PTO, and holidays.
• Parental leave program.
• Professional development opportunities (training, career development).
• Gym pass, employee perks program.
• 401(k) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute).
• Health insurance: Medical, Dental, Vision.
• Travel accident insurance; Life and AD&D Insurance, Short- & Long-Term Disability Insurance.
• Health Savings Account, Flexible Spending Account.
• Critical Illness, Accident, Hospital Indemnity coverages.
• Adoption benefits.

Location

North America: USA: TX-San Marcos, TX-Austin, or TX-San Antonio.